Under pressure to cut costs,
hospitals and health care providers are recycling and reusing disposable
medical devices such as biopsy forceps, invasive procedure catheters, saw
blades and drill bits after patient use. An increasingly common practice,
it is estimated that one-third or more of all U.S. hospitals routinely
reuse disposable medical devices labeled and approved for one time use.
At issue are medical devices and instruments labeled for single use that
hospitals and health care professionals deem recyclable. Unbeknownst to
patients, hospitals either reprocess the devices themselves and reuse them
or they send the instruments out to a third-party for reprocessing. Doctors
are not required to inform patients that a recycled medical device will
be used on them. There are no standards on the number of times a device
can be reprocessed. And patients are usually billed the same amount whether
a medical device is new or recycled.

Manufacturers began to sell
single use medical devices in the late 1970s in response to the demand
for disposable products by hospitals and health care providers. Prior to
this time most medical devices were constructed from glass, metal or rubber
and required only a simple sterilization process for reuse. Today, with
the advancement of medical technology, disposable medical devices are more
complex, smaller and constructed from plastic. Consequently, the devices
are often more delicate, less durable, and have the increased potential
for the transmission of infections. Moreover, the cleaning and sterilizing
of disposable instruments is more problematic, requiring sophisticated
cleaning and sterilizing methods. There is the potential with complex devices
that reliability and physical integrity may be compromised leading to increased
risks of patient infections or injury.

In recent months, medical
device manufacturers have waged a media campaign to publicize this practice
and to pressure the Food and Drug Administration (FDA) into reconsidering
current policies that allow hospitals to use reprocessed single use devices.
The issue is highly charged on both sides of the debate with high financial
stakes. Recycling medical devices is a $20 million a year industry and
growing. Hospitals and reprocessors maintain that the process is safe,
and the real issue is about economics, not patient safety. They argue that
the designation for single use is at the manufacturer's discretion and
is intended to increase sales. Medical device manufacturers counter that
scientific evidence to support the claim that the process is safe is lacking.

If original equipment manufacturers
want to market a single use medical device as reusable, they are required
to submit a 510(k) application to the FDA demonstrating that the medical
device can be recycled and reused safely. Hospitals that reprocess devices
in their own facilities are not similarly regulated. Third-party reprocessors
are only required to register with the FDA, follow production guidelines
and undergo spot inspections.

The literature contains few
independent studies on the safety of reusing single use medical devices.
The use of reprocessed medical devices is common in other countries with
mixed results. France and Australia recently banned the practice, but Canada
recently approved the reuse of medical devices.

The growing controversy over
the recycling of single use medical devices led Congress and the FDA to
seek federal solutions to the issue. In August 1999, Senator Richard Durbin
introduced a bill in the Senate (S. 1542) and in October 1999 a similar
measure was introduced in the U.S. House of Representatives (H.R. 3148)
by Representatives Anna Eshoo (D-California) and Fred Upton (R-Michigan).
The legislative measures will ensure greater FDA oversight of reprocessing,
requiring a pre-market review for any medical device intended for reuse
demonstrating that the device is safe for patient use after recycling.
The measures also require informed consent to be obtained from the patient
prior to use of a reprocessed device and the development of a monitoring
and reporting system for adverse outcomes. In September 1999, Congress
directed the U.S. General Accounting Office to conduct an investigation
into the extent of reuse and its effects on patient care.

Meanwhile, on November 1,
1999, the FDA announced a proposed strategy and is seeking public comment
on its recommendations for addressing the practice of reuse of single use
medical devices. The FDA's recommendations include regulating reprocessors
and hospitals that use recycled medical devices in much the same way it
regulates original equipment manufacturers. The FDA proposal calls for
a three-tiered system of regulation commensurate with the potential risk
posed from recycling the medical device. The FDA proposes removing "high
risk" single use devices from the market and establishing premarket requirements
for "medium risk" devices. "Low risk" medical devices would include products
that pose little or no risk to the public and would be exempt from premarket
requirements. On December 14, 1999, the FDA held a public meeting to gather
comments on its proposed strategy. See http://www.fda.gov/cdrh/reuse.